Whether a product is a cosmetic or a drug under the law is determined by a product's intended use. Different laws and regulations apply to each type of product. Firms sometimes violate the law by marketing a cosmetic with a drug claim or by marketing a drug as if it were a cosmetic, without adhering to requirements for drugs.

How does the law define a cosmetic?

The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines cosmetics by their intended use, as "articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance" [FD&C Act, sec. 201(i)]. Among the products included in this definition are skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, cleansing shampoos, permanent waves, hair colors, and deodorants, as well as any substance intended for use as a component of a cosmetic product.

How does the law define a drug?

The FD&C Act defines drugs, in part, by their intended use, as "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease" and "articles (other than food) intended to affect the structure or any function of the body of man or other animals" [FD&C Act, sec. 201(g)(1)].

How can a product be both a cosmetic and a drug?

Some products meet the definitions of both cosmetics and drugs. This may happen when a product has two intended uses. For example, a shampoo is a cosmetic because its intended use is to cleanse the hair. An antidandruff treatment is a drug because its intended use is to treat dandruff. Consequently, an antidandruff shampoo is both a cosmetic and a drug. Among other cosmetic/drug combinations are toothpastes that contain fluoride, deodorants that are also antiperspirants, and moisturizers and makeup marketed with sun-protection claims. Such products must comply with the requirements for both cosmetics and drugs.

What about "cosmeceuticals"?

The FD&C Act does not recognize any such category as "cosmeceuticals." A product can be a drug, a cosmetic, or a combination of both, but the term "cosmeceutical" has no meaning under the law.

How is a product's intended use established?

Intended use may be established in a number of ways. The following are some examples:

Claims stated on the product labeling, in advertising, on the Internet, or in other promotional materials. Certain claims may cause a product to be considered a drug, even if the product is marketed as if it were a cosmetic. Such claims establish the product as a drug because the intended use is to treat or prevent disease or otherwise affect the structure or functions of the human body. Some examples are claims that products will restore hair growth, reduce cellulite, treat varicose veins, increase or decrease the production of melanin (pigment) in the skin, or regenerate cells.

Consumer perception, which may be established through the product's reputation. This means asking why the consumer is buying it and what the consumer expects it to do.

Ingredients that cause a product to be considered a drug because they have a well-known (to the public and industry) therapeutic use. An example is fluoride in toothpaste.

This principle also holds true for "essential oils." For example, a fragrance marketed for promoting attractiveness is a cosmetic. But a fragrance marketed with certain "aromatherapy" claims, such as assertions that the scent will help the consumer sleep or quit smoking, meets the definition of a drug because of its intended use. Similarly, a massage oil that is simply intended to lubricate the skin and impart fragrance is a cosmetic, but if the product is intended for a therapeutic use, such as relieving muscle pain, it's a drug.

How are the laws and regulations different for cosmetics and drugs?

The following information is not a complete treatment of cosmetic or drug laws and regulations. It is intended only to alert you to some important differences between the laws and regulations for cosmetics and drugs in the areas of approval, good manufacturing practice, registration, and labeling. Questions regarding laws and regulations for drugs should be directed to FDA's Center for Drug Evaluation and Research (CDER).

How approval requirements are different

Under the FD&C Act, cosmetic products and ingredients, with the exception of color additives, do not require FDA approval before they go on the market. Drugs, however, must generally either receive premarket approval by FDA through the New Drug Application (NDA) process or conform to a "monograph" for a particular drug category, as established by FDA's Over-the-Counter (OTC) Drug Review. These monographs specify conditions whereby OTC drug ingredients are generally recognized as safe and effective, and not misbranded. Certain OTC drugs may remain on the market without an NDA approval until a monograph for its class of drugs is finalized as a regulation. However, once FDA has made a final determination on the status of an OTC drug category, such products must either be the subject of an approved NDA [FD&C Act, sec. 505(a) and (b)], or comply with the appropriate monograph for an OTC drug. (A note on the term "new drug": Despite the word "new," a "new drug" may have been in use for many years. If a product is intended for use as a drug, it must comply with the requirements outlined above.)

What do these terms mean?

An NDA is the vehicle through which drug sponsors formally propose that FDA approve a pharmaceutical for sale and marketing in the United States. FDA only approves an NDA after determining, for example, that the data is adequate to show the drug's safety and effectiveness for its proposed use and that its benefits outweigh the risks. The NDA system is also used for new ingredients and for new indications entering the OTC marketplace for the first time. For example, the newer OTC products (previously available only by prescription) are first approved through the NDA system, and their "switch" to OTC status is then approved, also through the NDA system.

FDA has published monographs, or rules, for a number of OTC drug categories. These monographs, which are published in the Federal Register, state requirements for categories of nonprescription drugs, such as what ingredients may be used and for what intended use. Among the many nonprescription drug categories covered by OTC monographs are

acne medications

treatments for dandruff, seborrheic dermatitis, and psoriasis

sunscreens

You can find information on FDA's website, under "Development and Approval Process (Drugs)," especially "How Drugs Are Developed and Approved." If you still have questions about NDAs and OTC monographs, or any other aspect of drug regulation, please contact CDER. You can contact CDER's Division of Drug Information, Small Business Assistance at CDERSmallBusiness@fda.hhs.gov or, for general drug-related inquiries, CDER's Division of Drug Information at druginfo@fda.hhs.gov.

How good manufacturing practice requirements are different

Good manufacturing practice (GMP) is an important factor in helping to assure that your cosmetic products are neither adulterated nor misbranded. However, while FDA has provided guidelines for cosmetic GMP (see "Good Manufacturing Practice (GMP) Guidelines/Inspection Checklist"), no regulations set forth specific GMP requirements for cosmetics. In contrast, the law requires strict adherence to GMP requirements for drugs, and there are regulations specifying minimum current GMP requirements for drugs [Title 21 of the Code of Federal Regulations (CFR), parts 210 and 211]. Failure to follow GMP requirements causes a drug to be adulterated [FD&C Act, sec. 501(a)(2)(B)].

A cosmetic product must be labeled according to cosmetic labeling regulations. See the Cosmetic Labeling Manual for guidance on cosmetic labeling and links to the regulations related to cosmetic labeling. OTC drugs must be labeled according to OTC drug regulations, including the "Drug Facts" labeling, as described in 21 CFR 201.66 Combination OTC drug/cosmetic products must have combination OTC drug/cosmetic labeling. For example, the drug ingredients must be listed alphabetically as "Active Ingredients," followed by cosmetic ingredients, listed in descending order of predominance as "Inactive Ingredients."

And what if it's "soap"?

Soap is a category that needs special explanation. That's because the regulatory definition of "soap" is different from the way in which people commonly use the word. Products that meet the definition of "soap" are exempt from the provisions of the FD&C Act because—even though Section 201(i)(1) of the act includes "articles...for cleansing" in the definition of a cosmetic—Section 201(i)(2) excludes soap from the definition of a cosmetic.

How FDA defines "soap"

Not every product marketed as soap meets FDA's definition of the term. FDA interprets the term "soap" to apply only when

the bulk of the nonvolatile matter in the product consists of an alkali salt of fatty acids and the product's detergent properties are due to the alkali-fatty acid compounds, and

the product is labeled, sold, and represented solely as soap [21 CFR 701.20].

Products that meet this definition of soap are regulated by the Consumer Product Safety Commission(CPSC), not by FDA. Please direct questions about these products, such as safety and labeling requirements, to CPSC.

If a cleanser does not meet all of these criteria...

If a product intended to cleanse the human body does not meet all the criteria for soap, as listed above, it is either a cosmetic or a drug. For example:If a product

consists of detergents, or

primarily of alkali salts of fatty acids, and

is intended not only for cleansing but also for other cosmetic uses,

it is regulated as a cosmetic. Examples of cosmetic uses include making the user more attractive, by acting as a deodorant, imparting fragrance to the user, or moisturizing the skin. If a product

consists of detergents, or

primarily of alkali salts of fatty acids, and

is intended not only for cleansing but also to cure, treat, or prevent disease, or to affect the structure or any function of the human body,

it is regulated as a drug, or possibly both a drug and a cosmetic. Examples include antibacterial cleansers and cleansers that are also intended to treat acne. If a product

is intended solely for cleansing the human body,

has the characteristics consumers generally associate with soap, and

does not consist primarily of alkali salts of fatty acids,

it may be identified in labeling as soap, but it is regulated as a cosmetic.

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